SN/T 0323.1-2007 进出口医疗器械检验规程 第1部分:一次性使用输液(血)器
时间:2024-05-18 02:28:55 来源: 标准资料网 作者:标准资料网 阅读:9059
基本信息
标准名称: | 进出口医疗器械检验规程 第1部分:一次性使用输液(血)器 |
英文名称: | Rules for the inspection of medical equipment for import and export-Part 1:Infusion and transfusion sets for single use |
中标分类: |
医药、卫生、劳动保护 >>
医疗器械 >>
医用卫生用品 |
替代情况: | SN/T 0967-2000 |
发布日期: | 2007-12-24 |
实施日期: | 2008-07-01 |
首发日期: | |
作废日期: | |
起草单位: | 国家认证认可监督管理委员会 |
出版日期: | |
页数: | 12页 |
适用范围
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前言
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目录
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引用标准
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所属分类: 医药 卫生 劳动保护 医疗器械 医用卫生用品
【英文标准名称】:StandardPracticeforSurfacePreparationandMarkingofMetallicSurgicalImplants
【原文标准名称】:金属外科植入物表面制备和标志的标准实施规程
【标准号】:ASTMF86-2004(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:2004
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.12
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:alkalinecleaner;cleaning;electropolishing;finalinspection;marking;metalimplants;passivation;surfacetreatment;Marking;Metallicsurgicalimplantmaterials--specifications;Passivationtreatments;Specimenpreparation(general);Surfacepreparat
【摘要】:Thesurfacetreatmentsdocumentedinthispracticeareintendedtoimprovethecorrosionresistanceofmetallicsurgicalimplantsmanufacturedfromiron,cobalt,titanium,andtantalumbasematerials.Ironparticles,ceramicmedia,andotherforeignparticlesmaybecomesmearedoverorimbeddedintothesurfaceofimplantsduringprocessingoperationssuchasforming,machining,tumbling,beadblasting,andsoforth.Theseparticlesshouldberemovedtominimizelocalizedrustformationandsuperficialblemishes.Thevariouschemicalandelectrochemicalsurfacetreatmentsspecifiedinthispracticeareintendedtoremoveobjectionablesurfacecontaminantsandtorestoremaximumcorrosionresistancetothepassiveoxidefilm.Theneedforanadditionalimplantsurfacetreatmentsuchassecondarypassivationinnitricacidshouldbeevaluatedforlocalizedimplantsurfacesthathaveelectrochemicalorlaserproductmarkingscreatedafterthefinalsurfacetreatment.1.1Thispracticeprovidesadescriptionofsurfacecharacteristics,methodsofsurfacepreparation,andmethodsofmarkingformetallicsurgicalimplants.Markingnomenclatureandneutralizationofendotoxinarenotspecifiedinthispractice(seeX1.3).Surfacerequirementsandmarkingmethodsincludedintheimplantspecificationshalltakeprecedenceoverrequirementslistedinthispractice,whereappropriate.1.2Thevaluesstatedininch-poundunitsaretoberegardedasstandard.ThevaluesgiveninparenthesesaremathematicalconversionstoSIunitsthatareprovidedforinformationonlyandarenotconsideredstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:3P.;A4
【正文语种】:英语
MIL-C-7078/4, MILITARY SPECIFICATION SHEET CABLE, ELECTRIC, AEROSPACE VEHICLE, MIL-W-5086/2 BASIC WIRES, COPPER SHIELD, 600 BOLT, 105 C (12 AUG 1970).,